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NCT00119015 · ClinicalTrials.gov registry record · Phase 4
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
A Phase 4 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT00119015: Clinical Trial Phase 4 study, sponsored by University of Chicago.
NCT00119015 is a Phase 4 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 102 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00119015, a Phase 4 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. The purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the active medication but does not contain the drug).
Primary Outcome
Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
Interventions
- DRUG Placebo
- DRUG Montelukast
- DRUG Fluticasone propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2005-07 |
| Est. Completion | 2009-01 |
| Phase | Phase 4 |
Why NCT00119015 stopped before completion
NCT00119015 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00119015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00119015 about?
NCT00119015 is a clinical study titled "The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis". Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. The purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the activ...
What is the current status of trial NCT00119015?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2005-07. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00119015?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG), Fluticasone propionate (DRUG).
Who is sponsoring clinical trial NCT00119015?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00119015's enrollment target sits among peer trials
102 764th of 2000 higher than 1,235 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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